Reference number
ISO/TS 17822-1:2014
© ISO 2024
Technical Specification
ISO/TS 17822-1:2014
In vitro diagnostic test systems — Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens — Part 1: General requirements, terms and definitions
Edition 1
2014-12
Retirada
Retirada (Edición 1, 2014)

Resumen

ISO/TS 17822-1:2014 is intended for

? IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and

? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.

This part of ISO/TS 17822 does not apply to

? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or

? quantitative nucleic acid-based in vitro diagnostic examination procedures.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2014-12
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 1
    Número de páginas
     : 22
  • Comité Técnico :
    ISO/TC 212
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